CLASS II Drug recall · Reported 31 Jul 2013 · FDA Enforcement Report
AmBisome (amphotericin B) liposome for injection, 50mg vial recalled
Astellas Pharma US is recalling AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For, distributed nationwide in the US. The recall was initiated on 19 Jun 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-820-2013
- FDA event ID
- 65496
- Recalling firm
- Astellas Pharma US, Northbrook, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jun 2013
- FDA classified
- 25 Jul 2013
- Reported
- 31 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Jun 2013 | Recall initiated by company | |
| 25 Jul 2013 | Classified by FDA | +36 days |
| 31 Jul 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.
Where it was distributed
Nationwide and Canada
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
Which lots are affected?
Lot #: 042267AA, Exp July 2015, 042287AA, 042289AA, 042291AA, Exp Aug 2015. Lot Numbers and Expiry Dates (for Canada distribution). LOT 042269AA, EXP 07/2015, LOT 0422C1AA, EXP 11/2015.
Where was it sold?
Nationwide and Canada
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Astellas Pharma US
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Astagraf XL (tacrolimus extended-release capsules) 0.5 mg recalledAstagraf Xl | Astellas Pharma US | Packaging Defects | Nationwide |
| Drug | CLASS I | Prograf (tacrolimus) capsules, USP, 0.5 mg recalledPrograf | Astellas Pharma US | Packaging Defects | Nationwide |
| Drug | CLASS II | Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial recalled | Astellas Pharma US | Other | Nationwide |
| Drug | CLASS II | Tarceva (erlotinib) Tablets, 150 mg recalled by Astellas Pharma US | Astellas Pharma US | Potency & Assay | Nationwide |
Other Ambisome (amphotericin B) Liposome recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | AmBisome (amphotericin B) liposome for Injection, 50 mg recalled | Gilead Sciences | Sterility | CA |